Protocol
10-138
Full Title
A Phase 1, Open-label, Multi-Center, Dose Escalation Study of the Safety and Pharmacokinetics of ASG-5ME Monotherapy in Subjects with Castration-Resistant Prostate Cancer
Purpose
The purpose of this study is to determine the highest dose of an investigational drug called ASG-5ME that can be given safely in men with advanced prostate cancer that cannot be successfully treated with standard therapies. ASG-5ME is composed of two parts: a monoclonal antibody that zeroes in on a protein called AGS-5 on prostate cancer cells, and a chemotherapy drug (monomethyl auristatin E) which the antibody delivers directly to those cancer cells.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have advanced prostate cancer that persists despite low levels of testosterone (50 ng/dL or less).
- Patients must be taking and agree to remain on a stable dose of luteinizing hormone-releasing hormone agonist therapy or GnRH antagonist for the duration of the study, unless they were surgically castrated.
- At least 4 weeks must have passed since completion of chemotherapy, radiation therapy, major surgery, or receipt of PC-SPES and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Michael Morris at 646-422-4469.
Disease(s)
Prostate Cancer
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
Related Diseases
